Being a common epidemic disease, diarrhea gravely jeopardizes human health. According the survey of the World Health Organization (WHO), diarrhea has the fourth highest lethality among various diseases, just following tumors, cardio/cerebral-vascular diseases and diabetes. The most direct complications of diarrhea are dehydration, electrolyte disturbance, and malabsorption. Rehydration and adequately sustaining on diet are recommended during the therapy, but rehydration per se cannot treat the origin of diarrhea, nor could significantly shorten the duration or number or amount of diarrhea, thus appropriate drug treatment is of necessity. WHO has proposed six criteria for diarrhea drugs as follows: (1) highly effective; (2) orally administrable; (3) combinable with oral rehydration solutions (ORS); (4) intestinally unabsorbable; (5) not affecting intestinal absorption, especially the absorption of glucose and amino acids; (6) resistant to a series of intestinal pathogens.
Smectite is the main component of bentonite, and is conventionally used as absorbents, etc. In recent years, it has been found that smectite can be used as a highly effective digestive tract mucoprotectant and an absorbent for viruses, bacteria and toxins thereof, and can be used for the treatment of various acute or chronic diarrheas.
In the researches, the results indicate that smectite have pathogen clearance and mucoprotective actions in digestive tract, and is a safe and highly effective anti-diarrhea drug and meets the criteria of WHO as above mentioned. In addition, smectite not only can clear pathogens and toxins thereof, but also exhibits digestive muco-barrier protecting, enhancing and repairing functions, and can improve the quality of mucous fluid, balance the normal flora, and promote regeneration and reparation of the epithelial cells.
Pharmacological tests and clinical-study results show that the pharmacological effects of smectite depend on its unique laminate structure, inhomogeneous electric distribution and glid-viscoplasticity, so that smectite can continuously and uniformly cover the digestive tract surface and exhibit therapeutic effects via electrostatic and physicochemical properties. Smectite has good therapeutic effects on various acute and chronic diarrheas, reflux esophagitis, chronic gastritis, peptic ulcer, irritable bowel syndrome, and inflammatory bowel diseases. Further, smectite exhibits significant therapeutic effects on some clinical stubborn diseases, such as stress ulcer, stomatitis and digestive complications caused by large dosed radio- or chemo-therapy. Thus, smectite expands clinical therapeutic means and is an ideal digestive muco-protectant at present.
Smectite has a high safety, is easily to be accepted by patients and is especially suitable for those patients who should be specifically cared in medications, such as infants, pregnant women, aged people and patients with hepato/renal dysfunction.
However, currently commercially available pharmaceutical dosage form of smectite is powder (dioctahedral smectite powder), but this dosage form still has some drawbacks, such, it is not convenient to take the powder; the dose can hardly be precisely controlled; and it should be homogenous stirred before oral administration of the power. The powder has sand sensation and bilgy odour, so that patients often feel unpleasant while taking the powder. On the other hand, the powder can hardly be precisely divided when it is administrated to infants and children by a reduced dose.